Ignite Creation Date:
2025-12-24 @ 11:33 PM
Ignite Modification Date:
2026-02-25 @ 11:01 PM
Study NCT ID:
NCT03893656
Status:
COMPLETED
Last Update Posted:
2019-10-10
First Post:
2019-03-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Retroperitoneoscopic Donor Nephrectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006547', 'term': 'Hernia'}], 'ancestors': [{'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 158}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-02-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'completionDateStruct': {'date': '2019-07-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-10-08', 'studyFirstSubmitDate': '2019-03-24', 'studyFirstSubmitQcDate': '2019-03-26', 'lastUpdatePostDateStruct': {'date': '2019-10-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-03-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-05-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Operation time', 'timeFrame': 'at the end of the surgery', 'description': 'time from onset to complete of surgery'}, {'measure': 'Blood loss', 'timeFrame': 'at the end of the surgery', 'description': 'amount of bleeding during surgery (mililiter)'}, {'measure': 'warm ishemia time', 'timeFrame': 'at the end of the surgery', 'description': 'time from renal artery and vein dissection of the kidney to the initiation of perfusion on the bench table.'}, {'measure': 'İntraoperative complications', 'timeFrame': 'at the end of the surgery', 'description': 'abnormal problems that may be seen during surgery and require additional intervention.'}, {'measure': 'incisional hernia', 'timeFrame': 'up to 2 years', 'description': 'abdominal incision or trocar site defects of donors'}, {'measure': 'postoperative complication', 'timeFrame': 'up to 1 month', 'description': 'abnormal problems that may be seen after surgery and require additional intervention or follow-up (grade I-V)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Living donor nephrectomy', 'Kindey transplantation', 'Retroperitoneoscopic donor nephrectomy', 'Hernia'], 'conditions': ['Transplant; Complication, Failure']}, 'referencesModule': {'references': [{'pmid': '7491680', 'type': 'RESULT', 'citation': 'Ratner LE, Ciseck LJ, Moore RG, Cigarroa FG, Kaufman HS, Kavoussi LR. Laparoscopic live donor nephrectomy. Transplantation. 1995 Nov 15;60(9):1047-9.'}, {'pmid': '21441855', 'type': 'RESULT', 'citation': 'Hsu JW, Reese PP, Naji A, Levine MH, Abt PL. Increased early graft failure in right-sided living donor nephrectomy. Transplantation. 2011 Jan 15;91(1):108-14. doi: 10.1097/TP.0b013e3181fd0179.'}, {'pmid': '30316352', 'type': 'RESULT', 'citation': 'Kumar A, Chaturvedi S, Gulia A, Maheshwari R, Dassi V, Desai P. Laparoscopic Live Donor Nephrectomy: Comparison of Outcomes Right Versus Left. Transplant Proc. 2018 Oct;50(8):2327-2332. doi: 10.1016/j.transproceed.2018.03.034. Epub 2018 Mar 16.'}]}, 'descriptionModule': {'briefSummary': 'to compare the results of right and left-sided retroperitoneoscopic donor nephrectomy (RDN).', 'detailedDescription': "This was a retrospective study evaluating demographics, intraoperative and postoperative data of 158 kidney donors who underwent RDN from January 2010 to August 2018. Two groups were created according to the side of the surgery including Right RDN (group 1) and left RDN (group 2). The results of the recipients' were also evaluated."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '57 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '158 consecutive kidney donors undergoing pure RDN for allotransplantation at Ondokuz Mayıs University from January 2010 to August 2018. All operations were performed by a single surgeon (E. O.).', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult donors\n* Kidney donors undergoing retroperitoneoscopic donor nephrectomy\n* Recipients of the kidneys\n* Donors with the consent form\n* Recipients with consent form\n\nExclusion Criteria:\n\n* open donor nephrectomies\n* donors without the consent form\n* Recipients without the consent form'}, 'identificationModule': {'nctId': 'NCT03893656', 'acronym': 'RDN', 'briefTitle': 'Retroperitoneoscopic Donor Nephrectomy', 'organization': {'class': 'OTHER', 'fullName': 'Samsun Liv Hospital'}, 'officialTitle': 'Retroperitoneoscopic Donor Nephrectomy: a Retrospective Single-center Study', 'orgStudyIdInfo': {'id': 'OMU KAEK (2019/79)'}}, 'contactsLocationsModule': {'locations': [{'zip': '55020', 'city': 'Samsun', 'country': 'Turkey (Türkiye)', 'facility': 'Samsun Liv Hospital', 'geoPoint': {'lat': 41.27976, 'lon': 36.3361}}, {'zip': '55030', 'city': 'Samsun', 'country': 'Turkey (Türkiye)', 'facility': 'Ondokuz Mayıs University', 'geoPoint': {'lat': 41.27976, 'lon': 36.3361}}], 'overallOfficials': [{'name': 'Saban Sarıkaya, Professor', 'role': 'STUDY_CHAIR', 'affiliation': 'Ondokuz Mayıs University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'It is not yet known if there will be a plan to make IPD available.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Samsun Liv Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ondokuz Mayıs University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator, MD', 'investigatorFullName': 'Mehmet Necmettin Mercimek', 'investigatorAffiliation': 'Samsun Liv Hospital'}}}}